Mode
Text Size
Log in / Sign up
N/A N=320 Randomized Single-blind Health Services Research

Improving Women's Health Through Coordinated Postpartum Planning

Maternal Death · Maternal Morbidity

Enrolled (actual)
320
Serious AEs
5.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants Attending a Comprehensive Postpartum Visit — 84; 89 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Enhanced Postpartum Care System (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Emory University
Primary completion
Jul 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Attending a Comprehensive Postpartum Visit
84; 89
SECONDARY
Number of Participants Attending Any Postpartum Visit
109; 116
SECONDARY
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered
18; 26; 141; 135
SECONDARY
Number of Participants for Whom Postpartum Diabetes Screening Was Performed
9; 14; 150; 147
SECONDARY
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered
14; 19; 22; 26
SECONDARY
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed
8; 11; 28; 34
SECONDARY
Number of Participants Receiving Postpartum Hypertension Screening
80; 81
SECONDARY
Number of Participants With Hypertension Receiving Postpartum Hypertension Screening
45; 48
SECONDARY
Number of Participants Using Contraception
119; 117; 86; 85
SECONDARY
Number of Participants Using Medication
21; 29; 17; 9
SECONDARY
Number of Participants With Ongoing Pregnancy Complications
2; 3; 4; 8
SECONDARY
Number of Participants Readmitted to the Hospital
6; 10; 16; 20
SECONDARY
Perceived Risk of Severe Maternal Morbidity (SMM)
35; 34; 66; 76; 40; 31
SECONDARY
Perceived Risk of Cardiovascular Disease
55; 58; 26; 31; 60; 52
SECONDARY
Number of Participants Using Primary Care
73; 79
SECONDARY
Number of Participants Using Specialty Care
94; 73
SECONDARY
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score
37; 26; 88; 92; 16; 23
SECONDARY
Satisfaction With Postpartum Care
88; 81; 90; 79; 91; 82
SECONDARY
Satisfaction With Provider at Postpartum Care Visit
4.7; 4.7; 4.7; 4.6; 4.7; 4.6
SECONDARY
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
47; 50; 18; 23; 43; 32
SECONDARY
Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery
31; 29; 23; 31; 41; 33

Summary

The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.

Eligibility Criteria

Inclusion Criteria

  • pregnant women between 20-34 weeks of gestation
  • have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
  • intend to deliver at Grady Memorial Hospital
  • speak English or Spanish
  • have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index [BMI] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)

Exclusion Criteria

  • adults unable to consent, infants, and prisoners
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05430815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search